The following data is part of a premarket notification filed by Vitrolife Sweden Ab with the FDA for Freezekit Cleave , Thawkit Cleave.
| Device ID | K150950 |
| 510k Number | K150950 |
| Device Name: | FreezeKit Cleave , ThawKit Cleave |
| Classification | Media, Reproductive |
| Applicant | VITROLIFE SWEDEN AB 3601 SOUTH INCA STREET Englewood, CO 80110 |
| Contact | Brett Sonet Glazar |
| Correspondent | Brett Sonet Glazar VITROLIFE SWEDEN AB 3601 SOUTH INCA STREET Englewood, CO 80110 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-08 |
| Decision Date | 2015-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350025910710 | K150950 | 000 |
| 07350025910703 | K150950 | 000 |